MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE "TRUEVIEW II", 4 MM, 30°, AUTOCLAVABLE; RIGID ARTHROSCOPE

Model Number A70941A

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/14/2024

Event Type  malfunction  

Manufacturer Narrative

The device was returned and the evaluation found no additional reportable malfunctions.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the rigid arthroscope had damage to the distal tip and the light post.The event was found during reprocessing.An arthroscopic diagnostic procedure was performed.The procedure was completed using the same set of equipment.There were no reports of patient harm.

• Brand Name: TELESCOPE "TRUEVIEW II", 4 MM, 30°, AUTOCLAVABLE
• Type of Device: RIGID ARTHROSCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg/de/germany 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg/de/germany 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18820298
• MDR Text Key: 337636695
• Report Number: 9610773-2024-00586
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K951354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A70941A
• Device Lot Number: 588821
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1